FDA MAUDE Database Research Articles

TCT-474 Adverse Events and Failure Modes Related to Impella CP: Insights From the FDA MAUDE Database

TCT-474 Adverse Events and Failure Modes Related to Impella CP: Insights From the FDA MAUDE Database

E-44 | Clinical Perspectives on Valvular and Subclinical Leaflet Thrombosis after Transcatheter Aortic Valve Replacement: Insights from the US FDA MAUDE Database

E-44 | Clinical Perspectives on Valvular and Subclinical Leaflet Thrombosis after Transcatheter Aortic Valve Replacement: Insights from the US FDA MAUDE Database

Adverse Events Associated With 3 Vitrectomy Platforms Reported to the US FDA MAUDE Database.

Purpose: To identify and describe adverse events (AEs) observed with real-world use of the following 3 vitrectomy platforms: Constellation (Alcon), Enhancing Visual Acuity (EVA, Dutch Ophthalmic Research Center), and Stellaris (Bausch + Lomb). Methods: All reports submitted to the US Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database between January 2010 and November 2021 that were associated with the 3 vitrectomy platforms were analyzed. Each report was reviewed for AEs or consequences and the type of complication noted. Duplicates and reports with an inadequate narrative to categorize the event were excluded. A descriptive analysis was performed for the prevalence of device-specific issues within each platform. Results: The analysis included 2534 reports (1738 Constellation, 117 EVA, 679 Stellaris). Overall, the most commonly reported complications involved the vitrectomy probe (n = 957 [37.8%]) and the central processing unit (n = 368 [14.5%]). Differences in the distribution of AEs among the platforms were noted, with vitrectomy probe issues being the most reported events for the Constellation and Stellaris and infusion issues for the EVA. Infusion issues most frequently led to reports of patient harm with the Constellation (31/1738 [1.8%]) and EVA (7/116 [6.0%]), while issues with the vitrectomy probe were reported with the Stellaris (11/679 [1.6%]). Conclusions: An analysis of real-world data in the MAUDE database highlighted the spectrum of device-specific AEs of greatest relevance to surgical practice. Familiarity with potential device complications will help minimize harm to patients.

Development of an Improved LASER-Resistant Endotracheal Tube.

Surgical fires, particularly within Otolaryngology, remain a surprisingly frequent and devastating complication of laser-related surgery in the oropharynx and airway; Current estimates suggest anywhere from 200 to 600 surgical fires per year in the United States, with 20%-30% of these occurring as a complication of laser surgery and 90%-95% of these occurring in the head and neck region. Unfortunately, the complications of laser surgery in the airway may include respiratory failure, airway burns with stenosis, and may result in mortality. The most commonly utilized endotracheal tube for protection against inadvertent laser strikes, the Laser-Shield II tube (Medtronic), was removed from the commercial marketplace in 2016 after cases of airway fires were reported as a result of feature deficiencies in the product (FDA MAUDE Database review). Since the demise of the Laser-Shield II tube, alternatives such as the Mallinckrodt laser tube and handmade reinforced tubes have been utilized, although shortcomings in design and features have made these options less appealing to practicing Otolaryngologists. Creating a laser-safe endotracheal tube is critical for safe upper airway surgery. This paper evaluates new technologies, materials, and technical innovations in endotracheal tubes that may advance patient safety in laser-assisted Otolaryngology procedures. This paper evaluates new technologies, materials, and technical innovations in endotracheal tubes that may advance patient safety in laser-assisted Otolaryngology procedures. First, this article reviews the background of laser surgery in Otolaryngology and the consequent risk of surgical fire with resultant development of laser-resistant endotracheal tubes and commercial availability. Next, a review of claims and national database review of product failures related to previous laser-resistant endotracheal tubes is performed through the FDA MAUDE database. This includes an evaluation of cases: review of techniques in laser airway surgery including spontaneous ventilation, decreased O2 concentration, currently available endotracheal tubes including "handmade" fixes for perceived safety risks, and determination of failure points for previous laser-resistant endotracheal tubes. Third, the paper reviews the requested features of an "ideal" laser-resistant endotracheal tube. Finally, the paper reviews failure testing from an initial, unsuccessful attempt at material development and the consequent development of alternative technologies that address failure points from previous endotracheal tubes and addresses requested features with a detailed analysis of FDA-approval required testing. Extensive lab testing of the new tube predicts a significant reduction of risk in vivo with inability to perforate the shaft or cuff of the tubes under standard working conditions. While no iteration of a laser-resistant endotracheal tube is entirely laser safe, advances in technology can improve the safety profile of these devices. The new tube contains a double cuff, a soft and flexible shaft to minimize laryngeal insertion trauma, a smooth external surface, a tight-to-shaft balloon, and methylene blue dye in the cuff to alert the user to inadvertent penetration. These characteristics were the most requested by laryngologists in the development of a new laser-resistant tube. The newest endotracheal tube brings the features most requested by Otolaryngologists in a laser-resistant tube, and improves the safety profile over previous tubes. Development of a new endotracheal tube represents an advancement in safety for the Otolaryngologist in laser airway surgery. Understanding the previous history and the science behind surgical fire formation is essential in advancing safety for patients in the future. N/A Laryngoscope, 134:S1-S12, 2024.

Evidence-based clinical engineering: Health information technology adverse events identification and classification with natural language processing

The primary goal of this project is to create a framework to extract Real-World Evidence to support Health Technology Assessment, Health Technology Management, Evidence-Based Maintenance, and Post Market Surveillance (as outlined in the EU Medical Device Regulation 2017/745) of medical devices using Natural Language Processing (NLP) and Artificial Intelligence. An initial literature review on Spontaneous Reporting System databases, Health Information Technologies (HIT) fault classification, and Natural Language Processing has been conducted, from which it clearly emerges that adverse events related to HIT are increasing over time. The proposed framework uses NLP techniques and Explainable Artificial Intelligence models to automatically identify HIT-related adverse event reports. The designed model employs a pre-trained version of ClinicalBERT that has been fine-tuned and tested on 3,075 adverse event reports extracted from the FDA MAUDE database and manually labelled by experts.

S9 Adverse Events and Device Failures Associated With Pancreatic Stents: A Comprehensive Analysis Using the FDA's MAUDE Database

S9 Adverse Events and Device Failures Associated With Pancreatic Stents: A Comprehensive Analysis Using the FDA's MAUDE Database

TCT-435 Adverse Events With Intravascular Lithotripsy After Coronary Use: A Report from the FDA MAUDE Database

TCT-435 Adverse Events With Intravascular Lithotripsy After Coronary Use: A Report from the FDA MAUDE Database

MP51-02 AQUABLATION POSTOPERATIVE BLEEDING RISK REDUCTION

You have accessJournal of UrologyCME1 Apr 2023MP51-02 AQUABLATION POSTOPERATIVE BLEEDING RISK REDUCTION Dean Elterman, Steven A. Kaplan, Lori Lerner, Brian Helfand, Mihir Desai, Neil Barber, Rick Popert, Philip Charlesworth, and Thorsten Bach Dean EltermanDean Elterman More articles by this author , Steven A. KaplanSteven A. Kaplan More articles by this author , Lori LernerLori Lerner More articles by this author , Brian HelfandBrian Helfand More articles by this author , Mihir DesaiMihir Desai More articles by this author , Neil BarberNeil Barber More articles by this author , Rick PopertRick Popert More articles by this author , Philip CharlesworthPhilip Charlesworth More articles by this author , and Thorsten BachThorsten Bach More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003299.02AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Aquablation was originally studied in two FDA clinical trials spanning the years of 2015-2017 (WATER in prostates ≤80 mL, WATER II in prostates ≥80 mL). Aquablation was granted approval by FDA in December of 2017. Since then, commercial users have adopted a refined focal cautery approach for hemostasis. METHODS: Consecutive, commercial patients undergoing Aquablation from Asia, Europe, and North America were evaluated for bleeding risk of transfusion and takeback over the last 4 years. The source for the reported bleeding events was the FDA MAUDE database that requires manufactures to report global incidents. RESULTS: 13,447 Aquablation cases were performed with a mean prostate size of 90 mL (range 12 to 535 mL). Following the introduction of the focal bladder neck cautery protocol in January 2020, Figure 1 demonstrates a remarkable decline in bleeding risk requiring an intervention (either a transfusion, takeback for cautery, or takeback for clot evacuation). In 2021 and 2022, the risk of transfusion has reduced to 0.3% and 0.2%, respectively. CONCLUSIONS: Aquablation has leveraged imaging and robotics to allow surgeons to treat the a broad range of prostate sizes. However, early learnings in the development of the procedure, surgeons realized a standardized hemostasis technique was nececessry. Following the adoption of the standardized protocol, the bleeding risk has been reduced by 10-fold and allowing some surgeons the option of day-case Aquablation. Source of Funding: Not applicable © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e692 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Dean Elterman More articles by this author Steven A. Kaplan More articles by this author Lori Lerner More articles by this author Brian Helfand More articles by this author Mihir Desai More articles by this author Neil Barber More articles by this author Rick Popert More articles by this author Philip Charlesworth More articles by this author Thorsten Bach More articles by this author Expand All Advertisement PDF downloadLoading ...

Adverse events with intravascular lithotripsy after coronary use: A report from the FDA MAUDE database.

Percutaneous coronary intervention (PCI) on heavily calcified lesions has been associated with more complications.1 Intravascular lithotripsy (IVL) was recently approved for treating de novo calcified coronary lesions based on excellent safety and efficacy on several studies, but there are limited "real world" outcomes. We conducted a comprehensive search of the MAUDE database between February 12, 2021, and February 28, 2023 using the manufacturer and brand name tabs with the keywords "Shockwave Medical" and "Shockwave," respectively. Given that a single IVL catheter can fail or cause multiple adverse events through different mechanisms, we considered all possible outcomes. The MAUDE database is freely accessible and de-identified, obviating the need for institutional review board approval.

Adverse Events and Modes of Failure of Thermocool and Arctic Ablation Catheter: Insights from the FDA MAUDE Database

Adverse Events and Modes of Failure of Thermocool and Arctic Ablation Catheter: Insights from the FDA MAUDE Database

Risk Analysis for Bakri Postpartum Balloon in Clinic

Object Analyze the adverse events of bakri postpartum balloon in order to promote its safety. Methods Collect and analyze the adverse events from the National Medical Device Adverse Event Monitoring Information System and the U.S. FDA MAUDE database. Chinese and English instructions for use are comparative analysed. Results In most cases, adverse events are balloon rupture and fluid leakage, which attribute to insufficient instruction. The description of the sequence that suturing the myometrium and filling the balloon is deficient. It should be moved gently to avoid puncturing or scratching the balloon with sharp instrument. Conclusion The product instruction improvement as well as training enhancement is recommended for safety consideration. Adverse events monitoring is suggested reinforce simultaneously.

Malfunction Events in the US FDA MAUDE Database: How Does Robotic Gynecologic Surgery Compare with Other Specialties?

To review malfunction events (MEs) related to the use of the da Vinci robot reported to the United States Food and Drug Administration Manufacturer and User Facility Device Experience in the last 10 years and compare gynecologic surgery with other surgical specialties. A retrospective review. Manufacturer and User Facility Device Experience database. Reports from 2010 to 2020 with keywords "Davinci" and "Intuitive". Report review. There were 679 reports included in the final analysis. Most MEs occurred intraoperatively (81.7%) and were related to robotic instrument malfunction (84.5%), and 30% required an instrument switch to complete the procedure. Conversion to open and laparoscopic surgery was required in 3.1% and 1.3% of MEs, respectively. Injury to the patient occurred in 15.6% of MEs. Of the reported injuries to patients, 6.6% were related to robotic malfunction, 49.2% to instrument malfunction, and 18% to surgeon or staff misuse of the robotic system, and 15.6% were complications inherent to the procedure, not related to the robotic system. Of all the reported MEs, 4.4% were related to robot malfunction, 1.5% to console malfunction, 73.3% to Intuitive accessory malfunction, 11.2% to other accessory malfunction, 4% to surgeon or staff misuse of robotic system, and 3% to complications inherent to the procedure. Comparison between gynecologic surgery and other surgical specialties showed that 14.4% of issues were solved intraoperatively in gynecologic surgery vs 13.7% in other specialties (p=.185). The procedure was completed robotically in 85.2% in gynecologic surgery vs 84% in other specialties, laparoscopically 4.6% vs 3.7%, and open in 10.2% vs 12.4%, respectively (p=.883). In gynecologic surgery, reported MEs were made by patients in 14.8% vs 4.8% in other specialties, manufacturer in 78.4% vs 74.2%, and operating room staff in 2.3% vs 16.1%, respectively (p=.007). Injury to patient was similar in gynecologic surgery compared with other specialties (35.1% vs 23.4%, p=.122). Gynecologic and other specialty MEs did not state the need for procedure rescheduling (0% vs 0%). Most reported robotic MEs occurred intraoperatively, were related to robotic instrument malfunctions, and required an instrument switch. Most surgeries are completed robotically, but conversion to either an open or laparoscopic approach was reported in 4.4%. Of the 114 reported injuries, 47.4% were Clavien-Dindo grade III+. There were no differences noted in patient injury between gynecologic surgery and other specialties.

48 Analysis of the US FDA MAUDE database - how does robotic gynecologic surgery compare to other specialties?

48 Analysis of the US FDA MAUDE database - how does robotic gynecologic surgery compare to other specialties?

Endovascular Stapler Complications During Minimally Invasive Nephrectomy: An Updated Review of the FDA MAUDE Database From 2009-2019

To characterize the rates of endovascular stapler complications during hilar ligation in minimally invasive radical nephrectomy over the last 10 years. We reviewed the Food and Drug Administration Manufacturer and User Facility Device Experience database from January 1, 2009 to August 1, 2019. Staplers were categorized according to type, namely Ethicon Inc. endocutters (Johnson & Johnson, New Brunswick NJ); Endo-GIA (Medtronic, Minneapolis MN); and Endo-TA (Medtronic, Minneapolis MN). There were 383 cases of complications involving staplers, 63% with Ethicon endocutters; 28% with GIA; and 9% with TA. 22 deaths (5.7% of total complications) were attributed to staplers. No deaths or reoperations occurred due to TA staplers. TA staplers were also associated with a reduced incidence of conversion to open as compared to Ethicon and GIA staplers. Apart from one device, manufacturer evaluation of returned devices either showed no abnormalities or attributed fault to improper use of staplers. We characterized stapler complications during a 10-year period for minimally invasive radical nephrectomy. No deaths or reoperations occurred due to TA staplers, perhaps due to cutting and stapling occurring in separate steps. Based on manufacturer evaluation attributing stapling malfunctions to human errors, training of operating room staff on proper use of these devices is critical to prevent potentially significant complications from occurring.

Creating a database for health IT events via a hybrid deep learning model.

The use of poorly designed and improperly implemented health information technology (HIT) may compound risks because it can disrupt established work patterns and encourage workarounds. Analyzing and learning from HIT events could reduce the risks and improve safety but are limited by accessible HIT event reports. In this study, we propose a hybrid deep learning model to identify HIT event reports from the FDA resource and thus establish the first publicly accessible database for HIT event reports. 6994 samples (3521 HIT and 3473 non-HIT events) extracted from the FDA MAUDE database were employed to assess nine individual and 120 hybrid models on the task of HIT identification. The optimal model was evaluated on an independent dataset prior to its application for establishing the HIT event database. The hybrid model consisting of logistic regression, CNN, and Hierarchical RNN (ACC=0.903, AUC=0.954, F1 score=0.876) is superior to all the other models. The causes of errors include lack of root cause (72.3%), short descriptions (19.7%), and model undertrained (8.0%). The accuracy of the hybrid model on an independent dataset is reported as 0.862. We applied the optimal model to the entire MAUDE database (1991-2018) and generated an HIT event database with 48,997 reports. The first HIT event database contains 48,997 reports with an annual growth rate of 10% (~5000 reports). The strategy of HIT event identification and establishment of the database could help healthcare professionals describe, understand, integrate the events and propose solutions in the context of a fuller spectrum of HIT events.

Comparison of Early Fatigue Failure of the TFNa and Gamma 3 Cephalomedullary Nails in the United States From 2015 to 2019.

To compare reports of implant fatigue failure submitted to the FDA of 2 commonly used cephalomedullary nails. In total, 2724 medical device reports from the FDA's MAUDE database from Jan 2015 to Oct 2019 were reviewed for the Trochanteric Femoral Nail-Advanced (TFNa) and Gamma 3 implants. Data from 342 implant failures included in the MAUDE database were analyzed. TFNa and Gamma 3 had 183 and 159 reported fatigue failures, respectively. All failed implants fractured in the same location through the proximal screw aperture. Time from implantation to failure was on average 2 months shorter for TFNa implants that were reported fractured than for Gamma 3 implants reported, a difference that was statistically significant (P < 0.05). In total, 100 implants were reported to have failed within the first 4 months (53 and 47 for TFNa and Gamma 3, respectively). For Gamma 3 implants that failed in the first 4 months, almost all of the available manufacturers' inspection reports revealed implant notches at the point of failure from drilling. For TFNa implants that failed early, only one reported notch was noted in the available inspection reports. In contrast to other studies regarding fatigue failure, reported failures in both TFNa and Gamma 3 occurred earlier than can be attributed to delayed or nonunion. The reported failures of the TFNa in the MAUDE database occurred earlier than did those of the Gamma 3. Early failures of the Gamma 3 seemed to be the result of iatrogenic implant notching. Therapeutic Level III. See instructions for authors for a complete description of levels of evidence.

1433 A 13 Year Review of Uterine Endometrial Ablation Device Events Using Categorization of Reports to the Manufacturer and User Facility Device Experience (Maude) Data Base

Study Objective Usefully categorize reports on endometrial ablation device events using the FDA MAUDE database. Design The FDA MAUDE database was reviewed using brand name searches: Novasure, Genesys HTA, Thermachoice, Minerva, and HerOption. Reported events were categorized as follows: Type I , non-injury equipment malfunction; Type II , an injury event not requiring hospitalization; Type III , an injury requiring hospitalization. Setting 13-year FDA MAUDE database review (2005-2018). Patients or Participants N/A. Interventions N/A. Measurements and Main Results 1518 MAUDE reports were categorized as follows: Novasure: Type I: 92/550 (16.7%), Type II: 273/550 (49.6%), Type III: 185/550 (33.6%); Genesys HTA: Type I: 140/432(32.40%), Type II: 259/432 (58.1%), Type III: 42/432 (9.49%); Thermachoice: Type I: 315/466 (67.60%), Type II: 78/466 (16.74%), and Type III: 73/466 (15.67%); Minerva: Type I: 13/56 (23.21%), Type II: 9/56 (16.07%), and Type III: 34/56 (60.71%); Her Option: Type I: 4/14 (28.57%), Type II: 0 (0%), and Type III:10/14 (71.43%). Novasure, Minerva, and Her Option had a greater percent of events due to bowel injury while Genesys HTA and Thermachoice had a greater percent of events due to vaginal/cervical/external thermal injuries. Over 50% of HTA Geneysis events were due to vaginal/cervical/external thermal injuries while greater than 50% of Novasure events were due to uterine perforation. Thermachoice had greater than 60% of events due to balloon rupture device malfunction. Conclusion The MAUDE database serves as a valuable tool for physicians to evaluate the safety and possible complications from existing and new technologies. Categorizing events as described here may improve clinicians’ ability to interpret MAUDE data. Large differences in report type were noted between brands of endometrial ablation devices. The percentage of Type III events by device were highest for HerOption, Minerva, and Novasure. Caution must be made when interpreting the data from the MAUDE database due to potential subjective and incomplete narrative, lack of outcome details, and erroneous or duplicate submissions.

Identifying Medical Equipment Usability Issues from Social Media Reports

Traditional methods of investigating usability include usability tests, heuristic evaluations, surveys, and field methods. User self-reports of equipment problems such as through the FDA MAUDE database are also available, but there may be limited information reported. Often, people turn to social media to share stories and learn from others. In this study, the authors explored using social media as a means of identifying possible usability issues with medical devices and products. As a proof of concept, the authors focused on insulin pumps, continuous glucose monitors, and sleep apnea machines. Reports of medical equipment use issues were grouped into three categories: 1) correct instructions for product use, 2) apparently inadvertent incorrect instructions for use and 3) instructions that encouraged or could promote deliberate misuse. Each of these has different implications for designers, clinical product review committee members, and clinicians.

Getting More Information From Glucose Meter Evaluations.

Glucose meter evaluations are common in publications and inform whether the meter meets the ISO 15197 specification. The ISO 15197 specifications, which are universally cited, leave 1% of results unspecified, which can be thought of as typical performance of results (99%) versus rare performance (1%). Suggestions are provided to extract more information from these evaluations, including rare performance, since highly discrepant results or failure to obtain a result can be observed in a glucose meter that has met the ISO 15197 specification. It is also recommended that when manufacturers perform evaluations, they analyze adverse events contained in the FDA MAUDE database. Finally, we point out an important problem with the ISO 15197 specifications.

500.08 Adverse Events and Modes of Failure Associated with the Filterwire EZ Embolic Protection System; The Utility of the FDA MAUDE Database

Embolic protection devices (EPDs) prevent distal embolization of atherothrombotic material during percutaneous interventions resulting in reduced microvascular obstruction, improved microcirculation, and tissue perfusion. The FilterWire EZ Embolic Protection System (Boston Scientific, Natick, MA) is